医疗器械技术文档清单

医疗器械技术文档清单（DMRLIST）1、器材规格，包括适当的图样、成分、配方、零件规格及软体规格Devicespecificationsincludingappropriatedrawings,composition,formulation,componentspecifications,andsoftwarespecifications技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1)设计输入ProductDesignInputPLPDI-XXXX-XXDHFFolder2)产品规格ProductDesignSpecificationPLPDS-XXXX-XXDHFFolder3)零件规格ComponentEvaluationReportXXXX-XXXXXDMRFolder4)塑胶件配方表FormulationControlReportXXXX-XXXDMRFolder5)图纸DrawingXXXX-XXXXXDMRFolder6)软件Software7)使用该产品的适用标准AppropriateStandardXXXXXXXXXStandardFolder2、制程规格，包括适当的设备规格、生产方法、生产程序、及行产环境规格Productionprocessspecificationsincludingtheappropriateequipmentspecifications,productionmethods,productionprocedures,andproductionenvironmentspecifications技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1)主要生产设备清单TheAppropriateEquipmentListPLPIE-MLT-XXXDMRFolder2)产品作业流程ProduceFlowChartPLC-XXXX-XXDMRFolder3)排拉表ProduceLinelayoutPLL-XXXX-XXDMRFolder3)产品工艺文件ManualEngineeringInstructionsMEI-XXXX-XXXDMRFolder4)产品的批号规定LotNoDefineInstructionEI-XXXXDMRFolder5)产品的灭菌方法和确认SterilizationmeansandvalidationDMRFolder6)灭菌验证SterilizationverificationDMRFolder7)培训程序ProcedureforTrainingPLQSP601QSPFolder8)一万级无尘房监控指引CleanroommonitorinstructionPLPIE-CWI-008CWIFolder9)设备维修与保养程序ProcedureforMaintenanceandRepairofDevicesPLQSP602QSPFolder10)制程控制程序ProcedureforProcessControlPLQSP704QSPFolder13)无尘房日常维护保养工作指示InstructionforCleanRoomMaintainPLPIE-CWI-039CWIFolder14)医疗产品转拉清拉工作指示InstructionforlinechangePLQAD-CWI-087CWIFolder3、品质保证程序及规格，包括允收基准及所使用的品保设备Qualityassuranceproceduresandspecificationsincludingacceptancecriteriaandthequalityassuranceequipmenttobeused技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1)品质保证计划QualityAssurancePlanPLQAP-XXXX-XXDMRFolder2)产品质量控制工作指示QualityControlInstructionQCI-XXXX-XXDMRFolder3)产品测试计划ProductTestPlanPLPTP-XXXX-XXDMRFolder4)接受标准与检验方法PLQAD-XXXX-XXDMRFolder5)计量校准控制程序ProcedureforManagementandCalibrationPLQSP708QSPFolder6)来料检验和测试程序ProcedureforInspectionandTestofIncomingMaterialsPLQSP803QSPFolder7)制程检验与测试程序ProcedureforInspectionandTestofProcessPLQSP804QSPFolder8)最终检验与测试程序ProcedureforFinalInspectionandTestPLQSP810QSPFolder4、包装及标签规格，包括所使用的方法及程序Packagingandlabelingspecifications,includingmethodsandprocessesused技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1)产品的标签、语言规定ProductLabeling,LanguagePLQAD-CWI-XXXDMRFolder2)标签LabelingDMRFolder3)使用说明书ManualDMRFolder4)包装作业指导书InstructionforpackageMEI-XXXX-XXDMRFolder5)医疗产品包装标识、标签、说明书控制工作指示Packing、Labeling、ManualcontrolinstructionPLQAD-CWI-086CWIFolder5、安装、保养、及服务程序和方法Installation,maintenance,andservicingproceduresandmethods技术文件Devicemasterrecord文件编号Doc.NoApplyornot保存位置Location1）货仓物料储存仓位指示StoremanagementInstructionPLSTO-CWI-005CWIFolder2）搬运、贮存、包装、防备和交付程序ProcedureforHandling,Storage,Packaging,PreservationandDeliveryPLQSP707CWIFolder